'Been through a lot': New Passage Bio CEO talks about 'rising tide'; Back in business with the FDA, BioMarin finds itself without a CMO

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William Chou

William Chou has a lot on his hands at Passage Bio as the Jim Wilson-founded biotech attempts a rebound following a rough year of executive departures, layoffs and pipeline pruning.

Chou himself recently departed another gene therapy developer that has essentially shuttered. Aruvant, from the Roivant web, ceased clinical development of a lentiviral gene therapy for beta thalassemia after enrolling seven patients, and a preclinical AAV gene therapy for patients with hypophosphatasia, the parent company announced this summer.

But Chou has experience bringing to market the first CAR-T cell therapy, Kymriah, which was under his watch at Novartis, and he’s intent on retaining the “brain power” at the 110-employee biotech that he now helms, the CEO told Endpoints News on his fourth day on the job.

“Building culture and building a cohesiveness is going to be so important as we move forward at Passage. It’s something that’s important for every biotech company,” Chou said, “but I know Passage has been through a lot, so really it’s something we’re going to focus on as we move forward.”

With two recent gene therapy approvals over at bluebird bio — and a third that Chou anticipates in sickle cell disease next year — and the FDA accepting BioMarin’s hemophilia A gene therapy for review, the Passage CEO thinks the tide is turning for biotechs attempting to create one-time treatments.

“A rising tide rises all ships, and we are a part of that,” he said, speaking over Zoom in front of a turtle named Swimmy, which his brother “foisted” upon him 16 years ago. If offered a turtle, don’t accept it, Chou mused, noting he’s Swimmy’s primary caretaker now that his children are in college.

It’s the potential patient impact that Passage Bio can have that attracted him to join the Philadelphia biotech, Chou said.

“I’ve had the privilege to work on two genetic medicine programs: one for patients with cancer and one for patients with sickle cell disease. And in both of those cases, have had the opportunity to dramatically changes patients’ lives. And once you get that feeling, you want that again in your next program,” Chou said from his home office in New Jersey, after spending the first three days on the job across state lines in the company’s Philly office. “That’s what we have the opportunity to do here at Passage for patients with CNS disease.”

An early focus on manufacturing and analytical capabilities also caught Chou’s attention, he said, noting he learned from the Kymriah rollout that a lot of lead time is required for a successful launch. Passage Bio has a manufacturing facility in the Princeton area, which Chou said he’ll be visiting soon as the biotech works through its three clinical-stage programs in central nervous system diseases: GM1 gangliosidosis, Krabbe disease and frontotemporal dementia.

— Kyle LaHucik

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Harold Bernstein

→ BioMarin is in the market for a CMO, just as they were last year.

Harold Bernstein has ventured off to Maze Therapeutics in the dual role of president, R&D and CMO, while Eric Green has been promoted to CSO at a biotech making precision medicines like its lead Pompe disease program MZE001 with a human genetics and functional genomics platform called COMPASS. Bernstein replaced Geoff Nichol as the medical chief of BioMarin in October 2021, and now JJ Bienaimé has a decision to make on a successor as the March 31 PDUFA date looms for its hemophilia A gene therapy, known as Roctavian in Europe and valrox elsewhere. Earlier, Bernstein was head of translational medicine, as well as VP of global medicines development and medical affairs at Vertex.

Green had been SVP of research and translational sciences, and before he helped co-found the biotech that launched with a $191 million round in 2019, he was an entrepreneur-in-residence at Third Rock and head of translational research for MyoKardia. Maze topped off its cash reserves with a $190 million Series C in January.

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Peter Maag

→ Peter Maag is taking over for Dominic Borie as CEO of California autoimmune disease biotech Kyverna Therapeutics, but Borie isn’t going anywhere, shifting to a new role as president of R&D. Maag, the former president and CEO of CareDx, was president of Novartis Diagnostics as part of his 11-year tenure with the Swiss pharma. Like Maze, Kyverna also enjoyed a big financing round in January, raising $85 million in a Series B as an IND gets submitted for its autologous anti-CD19 CAR-T therapy KYV-101 for lupus nephritis.

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Athena Countouriotis

→ For Laura Shawver, it’s on to the next challenge after Silverback’s reverse merger with ARS Pharmaceuticals as she runs the show at Capstan Therapeutics, a Penn spinout looking to unlock the potential of mRNA to help develop in vivo CAR-T therapies. A month removed from Capstan’s $165 million Series A reveal, Athena Countouriotis is chairing the board, while Michael Rosenzweig joins the squad as EVP, portfolio strategy and product development. Countouriotis, the chief executive at Turning Point until the $4.1 billion M&A deal with Bristol Myers Squibb this summer, picks up her second such appointment in as many months (she’s the new chair at Recludix Pharma). And her LinkedIn says she’s back as a CEO for little-known Avenzo Therapeutics, a biotech that’s pulled together $170 million, so we’ll keep our eyes peeled for future announcements on who contributed to the financing. Rosenzweig is a Merck Research Laboratories vet in oncology and immunology discovery who just completed a stint as an entrepreneur-in-residence at RA Ventures.

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Jenny Sundqvist

→ Developing the late-stage drug cobitolimod for ulcerative colitis, Stockholm’s InDex Pharmaceuticals will have a new CEO at the beginning of next year as Jenny Sundqvist takes over. During two separate stints at AstraZeneca, Sundqvist was the global brand manager for the asthma med Symbicort and head of the global research portfolio in oncology before she led commercial and strategy development at Isofol Medical, where she was promoted to chief commercial officer in January. Johan Giléus had been pinch-hitting in the CEO spot at InDex and will return to his role as CFO.

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Nicolas Poirier

→ It hasn’t been long since Alexis Vandier picked up the CEO hat at OSE Immunotherapeutics in July, but he’s already being seen out the door. The board has elected Nicolas Poirier, the company’s chief scientific director, to be his successor. Poirier has been with OSE since 2016 and started his career at Tcl Pharma.

→ JD Finley will lead what’s left of Carlsbad, CA-based Palisade Bio on an interim basis after CEO Thomas Hallam “ceased his duties” on Monday, as the release states. When it was known as Leading BioSciences, the biotech merged with Seneca Biopharma under Hallam’s leadership, but Palisade had to cut 20% of an already small workforce a few weeks ago as clinical trials continue with its GI drug LB1148. Finley became CFO not long before Hallam’s promotion to chief executive in 2017.

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Michelle McMurry-Heath

→ Michelle McMurry-Heath’s unexpected exit at BIO came without warning or reason early this week. Internal tensions reportedly culminated in McMurry-Heath’s resignation, and she’ll now serve the organization in an advisory role. McMurry-Heath had held the position for a little over two years and prior to that was with J&J. Now, BIO has plucked up longtime biotech exec and former GlycoMimetics CEO Rachel King to take over the mantle in an interim capacity. In the meantime, the search for a full-time replacement is now underway.

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Imran Babar

→ Frazier-backed TYK2 player Sudo Biosciences popped the cork with a $37 million Series A round in late September and has now picked up Imran Babar as CBO. The ex-OrbiMed VP co-founded the Rare Genomics Institute and had been business chief at Cydan II from 2018-21. “It seems pretty clear that TYK2 inhibitorsTYK2 inhibitors are now emerging as the next major class of anti-inflammatory therapeutics,” Sudo CEO Scott Byrd told Lei Lei Wu last month. “So we’re part of a big wave.”

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Eyal Attar

→ Founded by Sid Mukherjee, who chairs the scientific advisory board, Vor Bio has appointed Eyal Attar as CMO. Attar held the same title at Aprea Therapeutics since 2019, and he was senior medical director and IDH hematology medical lead during a five-year run at Agios. Going after acute myeloid leukemia with its hematopoietic stem cell therapy VOR33, the biotech’s in-house manufacturing facility in Cambridge, MA is now operational.

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Julie Maltzman

→ Run by ex-Forty Seven chief Mark McCamish, San Diego oncolytic virus upstart IconOVir Bio has welcomed Julie Maltzman as CMO. Maltzman, who just concluded her four years at Genentech as VP and global head of gastrointestinal and cancer immunotherapy, is the ex-VP of clinical development at Nektar whose pharma background also extends to stops at Gilead and GSK. It’s a tight three-person C-suite for now at IconOVir with McCamish, Maltzman and chief technology officer John Huynh leading the way on its preclinical candidate ICVB-1042.

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Jakub Simon

→ Two key posts have been filled at California vaccine maker Vaxcyte: Business chief Mark Wiggins comes from another CBO gig at Tracon Pharmaceuticals, and from 2003-09, he was EVP of corporate and business development for Biogen. Jakub Simon — who slides into the CMO slot after doing some consulting work for Vaxcyte — is the ex-director of clinical research for vaccines at Merck and, among other responsibilities, was the clinical lead for the Big Pharma’s Ebola program.

→ ARCH-backed Walden Biosciences, a kidney disease upstart that launched two years ago around this time with a $51 million Series A round, has recruited Peter Linde as CMO. Linde — the ex-project lead, clinical asset development at AbbVie — has also been Acceleron’s VP, medical research, and we had him in this space in March 2020 when he took the CMO job at Morphic Therapeutic.

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Patrick Genestin

→ One of our 2021 Women in Biopharma R&D honorees, Jen Nwankwo, has found a business chief at her AI shop 1910 Genetics. Patrick Genestin was previously the VP of business development and pipeline strategy with Hikma Pharmaceuticals, and in the back half of his 15-year tenure with Novartis, he was VP, business development & licensing at Sandoz, the generics business that Vas Narasimhan finally spun off in late August after much hemming and hawing.

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Clare Hunt

→ Clare Hunt has been promoted to chief people officer at Alector, which is partnering with GSK on its frontotemporal dementia drug AL001. Hunt joined Alector as head of people when there were only 25 staffers in 2017, and she was elevated to VP of people in September 2020. Alector is back in Peer Review after telling you about the arrivals of CFO Marc Grasso and CMO Gary Romano earlier this year.

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Dana Washburn

→ Shooting for a regulatory hat trick with Imcivree after two earlier approvals, Rhythm Pharmaceuticals has named Alexion vet Dana Washburn as SVP of clinical development. Washburn served as executive director and global medicine leader at Alexion, now the rare disease arm of AstraZeneca, and he was fleetingly the CMO at Lyra Therapeutics. With the initial obesity nod in November 2020, Imcivree (setmelanotide) then earned an approval for Bardet-Biedl syndrome a few months back — and hypothalamic obesity is next on Rhythm’s radar after its Phase II data drop in July.

→ Atlas-backed Rectify Pharmaceuticals — “the leaders in ABC transporter biology” in the words of CEO Rajesh Devraj — has tapped Xiaobing Li as chief development officer and Robert Hughes as EVP, drug discovery and preclinical development. Formerly the global program leader for Linzess at Ironwood and Zulresso at Sage, Li was recently chief portfolio officer with Clover; she’s also been Voyager’s head of program leadership and portfolio management. Hughes worked at Pfizer and Boehringer Ingelheim before becoming the head of molecular discovery at Disarm Therapeutics, and he has an Atlas connection from his time as an entrepreneur-in-residence.

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Juliette Han

→ Juliette Han over at Cambrian BioPharma is adding the CFO post to her résumé and will also retain her current role as COO. Han is also adjunct professor at Columbia Business School and academic advisor at Harvard Medical School. Prior to joining Cambrian in 2020, Han had gigs at Two Sigma Private Investments Group, Citadel and McKinsey New Ventures.

→ Araris Biotech has welcomed Filippo Mulinacci as CBO. Mulinacci joins the Swiss-based company from Basilea Pharmaceutica. Mulinacci also has experience under his belt from stints at Philochem, Roche and Serono.

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Paul Tiseo

→ Paul Tiseo has signed on as the first VP of clinical development at CNS biotech Cognition Therapeutics, which just celebrated its one-year anniversary as a public company. Tiseo is a Pfizer and Regeneron alum who joined Centrexion Therapeutics in 2018 as senior director of clinical development and spent the last three years there as executive director. Cognition is testing its lead asset CT1812 in Alzheimer’s disease and dementia with Lewy bodies, as well as in dry age-related macular degeneration.

→ A bevy of new clinical execs has congregated at Stew Campbell’s biotech that tackles the gut-brain axis, Axial Therapeutics: Gabriel Belfort (VP, clinical development sciences and operations) is a Takeda and Sage vet who just held the role of VP, clinical development sciences at Praxis Precision Medicines; Kelly Bourdon (head of clinical operations) is the ex-director of clinical operations at Scipher Medicine and a former clinical trial manager with Sarepta; Philinia Lehr (head of clinical trial recruitment) was previously a manager and clinical trial educator at Quintiles; and Margaret Nelson-Lowe (associate director, clinical operations) also left Praxis, where she was a senior clinical trial manager.

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Vincent Bille

→ French vaccines company Osivax has named Vincent Bille as chief manufacturing officer. Bille joins the company to help scale up the manufacturing process of its lead program and he has the experience to back it up — having spent 15 years as an independent consultant and as a former director of sales at Lonza.

→ Atlanta-based Femasys — a company focused on meeting women’s needs — has brought on Christine Thomas as SVP of regulatory and clinical affairs. Most recently, Thomas was with IQVIA MedTech, where she served as head of regulatory solutions. Thomas also brings with her experience from previous roles at Cardiac Science, GE Healthcare, Boston Scientific, Smiths Medical and RTI Surgical.

→ German CDMO Rentschler Biopharma has tapped Tobias Glueck as SVP, human relations. Glueck hails from Novartis Germany, where he was managing director, people & organization. Prior to that, Glueck was VP human resources at Cameron.

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Bobak Azamian

→ Starting an ad campaign called “Look at the Lids,” Demodex blepharitis biotech Tarsus Pharmaceuticals is revamping its board of directors, naming CEO Bobak Azamian as chairman after co-founder Michael Ackermann’s decision to exit the role. Merck alum Wendy Yarno will now be the lead independent director of a board that’s also expanded with the recent appointment of Scott Morrison. After retiring from EY in 2015, Morrison has taken board seats at such biotechs as Global Blood Therapeutics, Zai Lab and Vera Therapeutics.

→ While extending its cash runway with a $34.2 million direct offering, Axcella has made room for Robert Rosiello and Torben Straight Nissen on the board of directors. Rosiello became an executive partner at Flagship after three decades at McKinsey, and Straight Nissen is a senior partner at Flagship who held several roles at Pfizer, including VP, strategic portfolio management and planning, worldwide R&D.

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Adora Ndu

→ BridgeBio chief regulatory affairs officer Adora Ndu has clinched a spot on the board of directors at Nuplazid maker Acadia Pharmaceuticals, which just kicked off its “Rett Revealed” campaign to raise awareness for Rett syndrome. Ndu ended her five-year tenure at BioMarin in February as group VP, head of worldwide R&D strategy, scientific collaborations and policy.

→ Putting some extra pep in its step with positive Phase Ib data for its hearing loss drug DB-020 over the summer, Decibel Therapeutics has elected former Acceleron CFO Kevin McLaughlin to the board of directors. In addition to Decibel, McLaughlin is a board member at Stealth BioTherapeutics and Vericel.

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Jennifer Jarrett

→ Greg Verdine’s LifeMine Therapeutics liked being in Peer Review so much, it’s back for a second consecutive week as it welcomes Arcus COO Jennifer Jarrett to the board of directors. LifeMine brought in CSO Martin Stahl and head of CMC Louis Plamondon last week.

→ Here are some board appointments Peer Review didn’t get to last week that we wanted to bookmark: Mallinckrodt has handed out another board seat with the arrival of 34-year Pfizer alum Susan Silbermann after the Irish drugmaker brought Karen Ling into the fold in August; Paul von Autenried, who spent 10 of his 26 years at Bristol Myers as chief information officer, has replaced Adam Goulburn on the board at Science 37; and former J&J exec Michael Meyers, who left as CMO and chief development officer of Syndax in March, has become the 10th board member at Nuvalent.

→ To recap some of the appointments in Beth Bulik’s MarketingRx roundup:

Neera Chaudhary is taking over the CEO reins from Dave Imre at Imre, after her recent stint as president, North America at Ketchum and a prior role at Golin’s global healthcare business unit as president; after a three-year stint at Evoke as president, North America, Jen O’Dwyer is joining Harrison and Star as the company’s new CEO; and last, but not least, Relevate Health has passed down the CEO baton to Tim Pantello as he takes over for co-founder Jeff Spanbauer, who is transitioning to chairman of the board. Pantello comes in from Syneos Health, where he was president for almost three years.

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